Cleared Traditional

DISPOSABLE HEMOSTATS (K920298) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K920298 · Falcon Instruments, Inc. · General & Plastic Surgery device
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Aug 1992
Decision
202d
Days
Class 1
Risk

K920298 is an FDA 510(k) clearance for the DISPOSABLE HEMOSTATS. Classified as Hemostat (product code HRQ), Class I - General Controls.

Submitted by Falcon Instruments, Inc. (Bethesda, US). The FDA issued a Cleared decision on August 11, 1992 after a review of 202 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Falcon Instruments, Inc. devices

Submission Details

510(k) Number K920298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1992
Decision Date August 11, 1992
Days to Decision 202 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 115d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRQ Hemostat
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.